CEN ISO/TS 20443:2018

European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Message exchange
5 Conformance terminology and context as it
   relates to the ISO IDMP standards and
   corresponding technical specifications
6 Maintenance of IDMP data elements and IDMP identifiers
7 Why standardisation of identification of Medicinal
   Products is needed
8 General considerations
9 Information for an authorised Medicinal Product
10 Investigational Medicinal Product Identifier (IMPID)
Annex A (normative) - Medicinal Product
Annex B (normative) - Marketing authorisation
Annex C (normative) - Packaged Medicinal
        Product (including manufactured item and device)
Annex D (normative) - Ingredient, substance and strength
Annex E (normative) - Pharmaceutical product and device
Annex F (normative) - Clinical particulars
Annex G (normative) - Organisation
Annex H (normative) - Manufacturer/establishment
Annex I (normative) - Investigational Medicinal Product
Annex J (normative) - SPL documents
Annex K (informative) - Abbreviations
Bibliography

ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.